Product Classification

• Device: implant, endosseous, root-form
• Regulation Description: Endosseous dental implant.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Product Code: DZE
• Submission Type: 510(k)
• Regulation Number: 872.3640
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ANSI ADA Specification No.38 2000 (Reaffirmed 2010) Metal-Ceramic Dental Restorative Systems
• ISO 10993-14 First edition 2001-11-15 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products from ceramics
• ISO 14801 Second edition 2007-11-15 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants
• ISO 7405 Second edition 2008-12-15 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry
• ASTM F2024-10 Standard Practice for X-Ray Diffraction Determination of Phase Content of Plasma-Sprayed Hydroxyapatite Coatings
• AAMI/ANSI/ISO 10993-14:2001/(R) 2011 Biological evaluation of medical devices - Part 14: Identification and quantification of degradation products form ceramics
• ISO 5832-11:1994 Implants for surgery -- Metallic materials -- Part 11: Wrought titanium 6-aluminium 7-niobium alloy
• ISO 5832-3:1996 Implants for surgery -- Metallic materials -- Part 3: Wrought titanium 6-aluminium 4-vanadium alloy
• ISO 5832-2:1999 Implants for surgery - Metallic materials - Part 2: Unalloyed titanium
• ASTM F1377-08 Standard Specification for Cobalt-28 Chromium-6 Molybdenum Powder for Coating of Orthopedic Implants (UNS R30075)

Guidance Document

• Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible